Pamira SD 65/18 428773Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04035479156497), received between Jan 2, 2025 and Sep 15, 2026 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Positioning Problem

  This RV lead was explanted due to patient experiencing some regurgitation. Should additional information be received this file will be updated.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 50779326 ↗
• InjurySep 11, 2026Fracture

  This lead was explanted due to fracture. Should additional information be received, this file will be updated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734422 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  System was explanted due to infection. Should additional information be received, this file will be updated.

  Patient problems: Unspecified Infection

  MAUDE report 50550257 ↗
• InjuryAug 19, 2026High Capture Threshold

  This lead was explanted due to high pacing thresholds, greater than 5 at 1.5ms. No adverse patient events were reported. Should additional information become available, this file will be updated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50323857 ↗
• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 25773383 ↗
• InjuryMay 19, 2026Device Dislodged or Dislocated

  THIS LEAD WAS REPOSITIONED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25225340 ↗
• InjuryMar 26, 2026Device Dislodged or Dislocated

  THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706946 ↗
• MalfunctionNov 25, 2025Over-Sensing; Device Dislodged or Dislocated; Over-Sensing; Device Dislodged or Dislocated

  THIS LEAD WAS SUCCESSFULLY REPOSITIONED AFTER DISLODGEMENT AND A DROP IN R-WAVES, POSSIBLY DUE TO OVERSENSING. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23652541 ↗
• MalfunctionOct 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS LEAD WAS EXPLANTED DUE TO PATIENT BEING COMPLETELY NON-COMPLIANT WITH RESTRICTIONS ON ARM MOVEMENT AND USE OF SLING. THIS LEAD WAS PREVIOUSLY REPOSITIONED DUE TO DISLODGEMENT, POSSIBLY FROM TWIDDLERS SYNDROME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Twiddlers Syndrome

  MAUDE report 23430333 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 22899835 ↗
• InjuryAug 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT CAUSING PERFORATION TO THE HEART. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Cardiac Perforation

  MAUDE report 22709257 ↗
• MalfunctionJan 2, 2025Failure to Convert Rhythm; Failure to Convert Rhythm

  SYSTEM WAS IMPLANTED AND THE POCKET WAS CLOSED. A DFT WAS PERFORMED WHICH FAILED SO THE SYSTEM WAS EXPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057570 ↗
• MalfunctionJan 2, 2025Intermittent Capture; Ambient Noise Problem; Intermittent Capture; Ambient Noise Problem

  INTERMITTENT NOISE SEEN ON THE RV CHANNEL AND INTERMITTENT NON-CAPTURE SEEN IN AN RV LEAD MONITORING RECORDING TRANSMITTED TO HOME MONITORING. FULL LEAD EVALUATION WAS RECOMMENDED. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21052249 ↗